Using multiple biomarkers to predict renal and cardiovascular drug efficacy: Implications for drug development and registration

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1 Using multiple biomarkers to predict renal and cardiovascular drug efficacy: Implications for drug development and registration Hiddo Lambers Heerspink Department of Clinical Pharmacology University Medical Center Groningen The Netherlands

2 Content Chronic disease growing, hypertension/diabetes Despite treatment high Residual Risk Current strategy is to target a single drug to a single risk factor However, ultimate outcomes involve multiple risk factors Drugs have multiple effects Should we include multiple effects on multiple risk factors in the efficacy of the drug on CV/renal outcome? And if so, how to include in the registration and use of drugs

3 Event Rate/1 patient. years High residual risk for renal death in type 2 diabetes under optimal (antihypertensive) treatment in RCT s BP Prot + GFR RENAAL IDNT ALL Cancers De Zeeuw et al, European Nephrol 29

4 High residual risk warrents new approaches We need new drugs or new approaches Current strategy is to target a single drug to a single risk factor e.g. to blood pressure This is not a target per se, since by lowering the blood pressure, the intention is to lower renal and CV risk on the long run This may lead to the false assumption that we are treating that risk factor: if we have lowered it it should be good

5 RENAAL; Differential effect of antihypertensive treatment on proteinuria and BP has differential effect on ESRD Eijkelkamp et al; JASN 27

6 Multiparameter short term response determines long term effect Thus, not only the on-target (blood pressure) effect of the Angiotensin Receptor Blocker determines the long term outcome, but also its off-target effect on albuminuria Is such a multiple (off-target) effect of a single drug common?

7 Multiple effects of RAAS-intervention Several RAAS-inhibitors are on the market including classes like ACEi, ARB and DRI These are all registered as antihypertensives They all have additional renal and CV protective properties beyond blood pressure lowering Which additional effects? How do they relate to the renal outcome?

8 Multiple effects of RAAS-intervention Several RAAS-inhibitors are on the market including classes like ACEi, ARB and DRI These are all registered as antihypertensives They all have additional renal and CV protective properties beyond blood pressure lowering Which additional effects? How do they relate to the renal outcome?

9 Potassium (mmol/l) Systolic BP (mmhg) RENAAL/IDNT; Change in biomarkers at month 6 in ARB and placebo groups in type 2 diabetes Albuminuria (%) Uric acid (mg/dl) Hb (mg/dl) Change HbA1C (%) RENAAL IDNT RENAAL IDNT RENAAL IDNT -1 ** ** -4 ** ** -.8 ** **.2 ** ** * Smink et.al.clin Pharm & Ther 213 In Press

10 Cholesterol (mg/dl) Calcium (mg/dl) RENAAL/IDNT; Change in biomarkers at month 6 in ARB and placebo groups in type 2 diabetes Phosphate (mg/dl) BMI (kg/m²) Serum albumin (mg/dl) RENAAL IDNT RENAAL IDNT RENAAL IDNT *.1 ** -5.3 ** ** *.2.1 * ** Smink et.al Clin Pharm & Ther 213 In Press

11 Multiple effects of RAAS-intervention Several RAAS-inhibitors are on the market including classes like ACEi, ARB and DRI These are all registered as antihypertensives They all have additional renal and CV protective properties beyond blood pressure lowering Which additional effects? How do these additional effects relate to the renal outcome?

12 RENAAL; Effect of losartan vs placebo on albuminuria in type 2 diabetes Albuminuria (Change,%) 4 2 Placebo -2 35% Overall Reduction -4 Losartan p=< Time (months) Brenner et al; New Engl J Med 21

13 Hazard ratio ESRD RENAAL; Degree of initial albuminuria reduction (6 mo) predicts the long term renal risk in type 2 diabetes ESRD Albuminuria reduction (%) De Zeeuw et al; Kidney Int 24

14 RENAAL; Effect of treatment on serum potassium in type 2 diabetes Serum Potassium (mmol/l) Losartan Placebo Time (months) Miao Y et al; Diabetologia 211

15 RENAAL; Serum Potassium during treatment effect renal outcome (doubling Screat/ESRD) in type 2 diabetes Renal Outcome (cum inc, %) 8 Potassium Potassium< Time (months) Miao Y et al; Diabetologia 211

16 Conclusion and Question Antihypertensive drugs that intervene in the RAAS have many more short-term (off-target) effects then the on-target effect of blood pressure lowering These off-target effects include changes that contribute either in a positive or negative way on final CV/renal outcome Combining the off-target short term effects into a multiple Parameter risk Response Efficacy (PRE) score might give better prediction of final long-term renal and cardiovascular outcome?

17 Principle of the PRE score Blood pressure is related to renal/cv outcome: the higher the blood pressure the more risk. There is thus a algorithmic relation between BP and CV/renal risk Assume a drug lowers the blood pressure. One can calculate from the above algorythmic relation how much renal/cv risk reduction could be anticipated. In RENAAL study losartan lowered blood pressure more than placebo. If the drug only had an effect on BP, this can thus be translated to an expected outcome of RENAAL.

18 Predicted long-term renal risk change (%) Systolic BP (mmhg) RENAAL; Predicting long term RENAL outcome in type 2 diabetes using the SBP effect at 6 mo of ARB tx ** -4-2 Smink et.al.; Clin Pharm & Ther 213 In Press

19 Principle of the PRE score The higher albuminuria the more renal/cv risk. Losartan lowered albuminuria more then placebo. Assuming losartan would only lower albuminuria, one can again predict how renal/cv risk reduction would occur.

20 Predicted long-term renal risk change (%) Albuminuria (%) RENAAL; Predicting long term RENAL outcome in type 2 diabetes using the albuminuria effect at 6 mo of ARB tx ** Smink et.al.; Clin Pharm & Ther 213 In Press

21 Principle of the PRE score The higher the serum potassium the more renal/cv risk. Losartan increased serum potassium more then placebo. Assuming losartan would only increase serum potassium, one can again predict how renal/cv risk increase would occur.

22 Predicted long-term renal risk change (%) Potassium (mmol/l) RENAAL; Predicting long term RENAL outcome in type 2 diabetes using the Potassium effect at 6 mo of ARB tx ** Smink et.al.; Clin Pharm & Ther 213 In Press

23 Predicted long term renal risk reduction after 6 months ARB treatment (%) RENAAL; Predicting long term RENAL outcome in type 2 diabetes using the PRE score at 6 mo of ARB tx 2-2 Observed renal risk reduction -22% (-35 to -6) -4 Smink et.al.; Clin Pharm & Ther 213 In Press

24 Validation of the PRE score (a multiple risk response score): score developed in RENAAL and applied to IDNT) Relative renal risk change (%) Renal outcome predicted ARB effect observed ARB effect Smink et.al.; Clin Pharm & Ther 213 In Press

25 Use of the PRE score The PRE score can thus be used in estimating renal protection for RAASi antihypertensive medications in diabetes Can it be used for CV protection?

26 Predicted long-term CV risk change (%) RENAAL; Predicting long term CV outcome in type 2 diabetes using the PRE score at 6 mo of ARB tx Observed cardiovascular risk reduction -9%(-24 to +8) Smink et.al.; Clin Pharm & Ther 213 In Press

27 Validation of the PRE score (a multiple risk response score): score developed in RENAAL and applied to IDNT) Relative cardiovascular risk change (%) CV Outcome predicted ARB effect observed ARB effect Smink et.al.; Clin Pharm & Ther 213 In Press

28 CONCLUSIONS Cardiovascular/Renal risk is determined by multiple different risk factors such as age, high blood pressure, cholesterol etc Multiple risk scores (like Framingham/ UKPDS score) determine the CV/renal risk of subjects. The risk scores are based on the combination of single parameters that each affect CV/renal outcome. Targeting and lowering the modifiable individual risk parameters with different single drugs is the current treatment guideline, and should lead to CV/renal protection Drug registration is based on the effect of a single drug on such a risk factor (hypertension, cholesterol etc) and will usually require a post registration validation on hard outcomes (of which many fail!)

29 CONCLUSIONS However, single drugs affect usually not only the one target parameter, but may have off-target effects Such off-target effects may affect the CV/renal outcome as much or more then the on-target effect This off-target effect can be positive or negative on CV/renal outcome Thus, the composite effect on all identifiable risk factors determines the ultimate CV/renal outcome The registration of drugs should reflect these multiple effects

30 Advantages of the PRE score Optimize Hard Outcome Trial Design Phase IIb/Phase III (hard outcome trials): Better prediction of the potential results of drugs on CV/renal Cost effectiveness Pharma (prevent starting or early stopping of potential negative trials) Less patient exposure/burden

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